1. Field of the Invention
The present invention relates, generally, to medical devices and methods, and, more particularly to a device for applying a gentle, controlled suction pressure to a human nipple/areola. The device and method are useful for correcting flat, inverted or retracting nipples to improve latch-on of an infant during breast feeding or for cosmetic reasons.
2. Background Information
A nipple flattens, retracts or inverts due to tiny bands of connective tissue, or adhesions, which attach the nipple to the breast tissue and pull the nipple inward. Flat, inverted or retracting nipples may be particularly troublesome to a woman who is attempting to breast feed her baby. If the baby is unable to latch onto the breast, the baby cannot feed and the lack of effective suckling could lead to lactation failure.
Various devices are known in the art for correction of flat, inverted or retracting nipples, i.e., devices which evert the nipple. One device used for treatment of inverted nipples is disclosed by Kesaree, et al., Treatment of Inverted Nipples Using a Disposable Syringe, J. Hum Lact 9(1), 1993, at 27-29. This device is constructed using a conventional syringe which is cut one centimeter from the nozzle. The piston is then inserted into the cut end and the smooth end is placed over the user's areola. The user then pulls out the piston to maintain a steady pressure and evert the nipple. A drawback of this device, however, is that it requires a cutting procedure to modify a syringe which is not designed to fit over a nipple. Further, if a user has a large nipple, the smooth end may not fit over the areola and the chances of damage to the nipple and surrounding tissue may be increased.
The NIPLETTE, which is manufactured by Cannon Babysafe, is also designed to correct inverted nipples. The Niplette includes a cap for placement over a nipple and a short tube connected to the cap. A syringe is connected to a valve at the open end of the tube to create suction pressure and evert the nipple. The syringe is then removed and the cap and tube are worn during the day and/or at night. A drawback of this device is that it must be worn continuously. In addition, the device may not be suitable for use on lactating breasts and is not recommended for use during the last two months of pregnancy. The device is also relatively expensive.
Another device for everting nipples is commonly known as a breast shell or milk cup. This device is worn prenatally and/or between feedings. A drawback of this device is that it sometimes promotes leakage of milk due to continuous pressure and is often not adequately ventilated, possibly causing skin breakdown. In addition, this device may cause mastitis due to pressure on tissue behind the nipple.
Another device which helps to evert the nipple is known as a nipple shield, which is worn over the nipple during breast feeding. Drawbacks of this device are that it decreases milk production with prolonged usage and may promote sore nipples and tissue breakdown by holding moisture next to the skin. Moreover, it is often necessary to use one hand to hold the device on the breast while breast feeding. Still another device for correcting flat, inverted or retracting nipples is a breast pump. This type of device often requires complicated assembly and may be quite costly.
Despite the need in the art for an apparatus and method of using the apparatus which overcome the disadvantages, shortcomings and limitations of the prior art, none insofar as is known has been developed.